Safety Study of EMD 72000 in Combination With ECX (Epirubicin, Cisplatin and Capecitabine) in Oesophagogastric Cancer

A Phase I Study to Determine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Three Doses of Humanised EGFR Antibody EMD 72000 in Combination With ECX in Patients With Advanced Oesophagogastric Adenocarcinoma

The main purpose of this study is to test the safety and tolerability and effectiveness of a new treatment, EMD 72000 (matuzumab), for advanced oesophagogastric cancer in combination with the chemotherapy regimen ECX (epirubicin, cisplatin and capecitabine).

In addition the study will look at pharmacokinetic (how the the body takes up the drug) and pharmacodynamic parameters (what the drug does in the body).

Inclusion Criteria:

• Advanced, recurrent or metastatic gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus
• EGFR positive tumor
• KPS greater than 60
• Normal cardiac function
• Adequate liver and bone marrow function
• GFR greater than 60 ml/minute

Exclusion Criteria:

• Previous chemotherapy
• Uncontrolled angina pectoris, heart failure, clinically significant uncontrolled cardiac arrythmias
• Clinically significant ECG or cardiac history
• Radiotherapy or surgery within last 4 weeks